title: Effect of oropharyngeal povidone-iodine preventive oral care on ventilator-associated pneumonia in severely brain-injured or cerebral hemorrhage patients: a multicenter, randomized controlled trial.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of oral care with povidone-iodine on the occurrence of ventilator-associated pneumonia in a high-risk population.
  
  
  METHODS
  A multicenter, placebo-controlled, randomized, double-blind, two-parallel-group trial performed between May 2008 and May 2011.
  
  
  METHODS
  Six ICUs in France.
  
  
  METHODS
  One hundred seventy-nine severely brain-injured patients (Glasgow Coma Scale ≤ 8) or cerebral hemorrhage expected to be mechanically ventilated for more than 24 hours.
  
  
  METHODS
  Participants were randomly assigned to receive oropharyngeal care with povidone-iodine (n = 91) or placebo (n = 88) six times daily until mechanical ventilation withdrawal.
  
  
  RESULTS
  Primary endpoint was the rate of ventilator-associated pneumonia. Secondary endpoint included the rates of ventilator-associated tracheobronchitis and acute respiratory distress syndrome and patient's outcome. The number of patients evaluable for the primary endpoint (preplanned modified intention-to-treat population) was 150 (78 in the povidone-iodine group, 72 in the placebo group). Ventilator-associated pneumonia occurred in 24 patients (31%) in the povidone-iodine group and 20 (28%) in the placebo group (relative risk, 1.11 [95% CI, 0.67-1.82]; p = 0.69). There was no significant difference between the two groups for ventilator-associated tracheobronchitis: eight patients (10%) in the povidone-iodine group and five patients (7%) in the placebo group (relative risk, 1.48 [95% CI, 0.51-4.31]; p = 0.47). Acute respiratory distress syndrome occurred in five patients in the povidone-iodine group but not in the placebo group (p = 0.06). There was no difference between groups for ICU and hospital lengths of stay, as well as ICU and 90-day mortality.
  
  
  CONCLUSIONS
  There is no evidence to recommend oral care with povidone-iodine to prevent ventilator-associated pneumonia in high-risk patients. Furthermore, this strategy seems to increase the rate of acute respiratory distress syndrome.
authors.affiliation: 1Département d'Anesthésie Réanimation, Centre Hospitalier Universitaire, Rennes, France. 2Inserm U991, Rennes, France. 3Université Rennes 1, Rennes, France. 4Service de Pharmacologie, Centre Hospitalier Universitaire, Rennes, France. 5Centre d'Investigation Clinique, Inserm 0203, Rennes, France. 6Département d'Anesthésie Réanimation, Centre Hospitalier Universitaire, Poitiers, France. 7Inserm Eri 23, Poitiers, France. 8Université Poitiers, Poitiers, France. 9Département d'Anesthésie Réanimation, Centre Hospitalier Universitaire, Nantes, France. 10Département d'Anesthésie Réanimation, Réanimation Chirurgicale, Centre Hospitalier Universitaire, Rouen, France. 11Département d'Anesthésie Réanimation, Centre Hospitalier Universitaire, Angers, France. 12Service de Bactériologie-Hygiène, Centre Hospitalier Universitaire, Rennes, France. 13EA 1254 Microbiologie-Risques Infectieux, Université de Rennes 1, Rennes, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Seguin
authors.forename: Bruno
authors.initials: B
authors.lastname: Laviolle
authors.forename: Claire
authors.initials: C
authors.lastname: Dahyot-Fizelier
authors.forename: Romain
authors.initials: R
authors.lastname: Dumont
authors.forename: Benoit
authors.initials: B
authors.lastname: Veber
authors.forename: Soizic
authors.initials: S
authors.lastname: Gergaud
authors.forename: Karim
authors.initials: K
authors.lastname: Asehnoune
authors.forename: Olivier
authors.initials: O
authors.lastname: Mimoz
authors.forename: Pierre-Yves
authors.initials: PY
authors.lastname: Donnio
authors.forename: Eric
authors.initials: E
authors.lastname: Bellissant
authors.forename: Yannick
authors.initials: Y
authors.lastname: Malledant
mesh_terms: D000891:Anti-Infective Agents, Local / Q000008:administration & dosage / Q000627:therapeutic use*; D001930:Brain Injuries / Q000628:therapy*; D002543:Cerebral Hemorrhage / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007362:Intensive Care Units; D008297:Male; D008875:Middle Aged; D009960:Oropharynx; D053717:Pneumonia, Ventilator-Associated / Q000517:prevention & control*; D011206:Povidone-Iodine / Q000008:administration & dosage / Q000627:therapeutic use*; D012121:Respiration, Artificial / Q000009:adverse effects / Q000379:methods
chemical_list: D000891:Anti-Infective Agents, Local; D011206:Povidone-Iodine